1.1 本实践使用质量风险管理（QRM）和生命周期方法来建立一次性使用系统（SUSs）的完整性保证，例如但不限于用于（生物）药品加工、储存和运输的袋组件和液体转移装置。它给出了识别与此类系统及其用例相关的故障模式和风险以及如何识别相关泄漏的建议。在这种情况下，完整性保证仅限于SUS的屏障特性，与微生物完整性和生物负载控制（产品质量）以及液体产品损失（操作员和环境污染）有关。所需的完整性保证级别将取决于应用程序的重要性，并可以以不同的方式进行解释。不考虑与之不同的其他包装阻隔性能，例如但不限于用于气体顶空保存的气体阻隔性能。 1.2 测试方法概述提供的描述侧重于标准测试设置和识别与SUSs结合的挑战。不讨论细节，包括具体的测试设置、测试参数和结果解释。 1.3 本规程不适用于主要容器、组合产品（由药物、装置或生物产品的任何组合组成的产品）或装置的一次性使用技术。涵盖主要容器完整性保证的文件中讨论了与这些产品相关的适当程序 ( 1. ) 2. 或医疗产品 ( 2. , 3. ) . 1.4 也没有讨论与完整性故障相关的投诉管理和根本原因分析的技术和程序。 1.5 以国际单位制表示的数值应视为标准值。 本标准不包括其他计量单位。 1.6 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.7 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 本惯例规定: 4.1.1 考虑到SUS从开发到处置的生命周期，评估与完整性违约相关风险的整体方法。 4.1.2 适用于SUS测试的物理和微生物测试方法概述，用于鉴定和验证目的，以及常规测试。 4.1.3 有关测试SUS完整性时面临的主要挑战的信息。 4.2 SUS供应商和SUS最终用户可以使用此实践来定义SUS的完整性保证策略，并在适当时进行相关测试。

1.1 This practice uses quality risk management (QRM) and life-cycle approach to establish integrity assurance of single-use systems (SUSs), such as but not limited to bag assemblies and liquid transfer sets for processing, storage, and shipping of (bio)pharmaceutical products. It gives recommendations to identify failure modes and risks associated with such systems and their use-cases and how to identify the relevant leak(s) of concern. Integrity assurance in this context is limited to the barrier properties of the SUS, linked to microbial integrity and bioburden control (product quality) and liquid product loss (operator and environmental contamination). The required level of integrity assurance will depend on how critical the application is and can be interpreted in different ways. Other package barrier properties different from that, such as but not limited to gas barrier properties for gas headspace preservation, are not considered. 1.2 The test method overview provides descriptions that focus on the standard test setup and the identification of challenges in combination with SUSs. Details, including specific test setups, test parameter, and result interpretation, are not discussed. 1.3 This practice is not intended to apply to the use of single-use technology for primary containers, combination products (products composed of any combination of a drug, device, or biological product), or devices. Appropriate procedures related to these products are discussed in documents covering the integrity assurance for primary containers ( 1 ) 2 or medical products ( 2 , 3 ) . 1.4 Techniques and procedures for complaint management and root cause analysis related to integrity failures are also not discussed. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 This practice provides: 4.1.1 A holistic approach to evaluate risks associated with an integrity breach in a SUS, considering its life cycle from development to disposal. 4.1.2 An overview of physical and microbial test methods that could be applicable to SUS testing, for qualification and validation purposes, as well as for routine testing. 4.1.3 Information on the main challenges faced when testing SUSs for integrity. 4.2 This practice can be used by SUS suppliers and SUS end users to define an integrity assurance strategy for SUSs, with the relevant tests when appropriate.